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United States · US · US:24208-431_4d7aecbc-8808-0b52-e063-6394a90a72a8

Opcon-A

Orange BookUNIISPLATC R01AA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeR01AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2420843115
    1 BOTTLE, DROPPER in 1 CARTON (24208-431-15) / 15 mL in 1 BOTTLE, DROPPER
  • ndc11
    2420843145
    2 BOTTLE, DROPPER in 1 CARTON (24208-431-45) / 15 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
MZ1131787D
NAPHAZOLINE HYDROCHLORIDE
RxCUI 82054
Orange Book
N020065
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MZ1131787D",
    "rxcui": "82054",
    "inchikey": "DJDFFEBSKJCGHC-UHFFFAOYSA-N",
    "display_name": "NAPHAZOLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5": {
      "match": "brand_token",
      "title": "OPCON-A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]",
      "spl_version": "2",
      "published_date": "2026-03-24"
    }
  },
  "productid": "24208-431_4d7aecbc-8808-0b52-e063-6394a90a72a8",
  "productndc": "24208-431",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "020065",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.02675%;0.315%",
        "product_no": "001",
        "approval_date": "Jun 8, 1994"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE",
  "proprietary_name": "Opcon-A",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA020065",
  "marketing_category": "NDA",
  "nonproprietary_name": "Naphazoline hydrochloride and Pheniramine maleate",
  "start_marketing_date": "20260319",
  "active_numerator_strength": ".2675; 3.15"
}

Related drugs

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